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510(k) Data Aggregation

    K Number
    K093205
    Device Name
    PADCHECK
    Manufacturer
    Date Cleared
    2010-04-01

    (170 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PADTEST, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PADChek™ ABI/PVR is a non-invasive device used to assist in the detection of peripheral artery disease (PAD). Pressure measurements at the ankles (dorsalis pedis and/or posterior tibialis arteries) are compared to the highest pressure in either arm (brachial arteries) and a ABI (Ankle Brachial Index) is calculated. A Pulse Volume Recording (PVR) is simultaneously performed to determine the presence of blood flow. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.
    Device Description
    PADCHEK ABI/PVR performs an Ankle Brachial Index (ABI) test by measuring systolic BP at the brachial artery in each arm and systolic BP at the dorsalis pedis and/or posterior arteries The ABI is expressed as the ratio of ankle systolic pressure divided by the at the ankles. highest brachial systolic pressure. A result is obtained for each leg. A pulse wave pattern and pulse volume recording is recorded for each limb measurement. A sitting BP, pulse, pulse pressure at the brachial artery is also obtained. Results are stored in a database and can be printed at the time of point-of-care testing or later.
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